The cyber division of the FBI released a report in 2022 stating that 53% of digital medical devices in hospitals had known critical vulnerabilities. As technology and connectivity becomes more predominant in the medical field, the concern of patient information being illegally obtained via the internet has risen.
The FDA issued this document on March 30th, 2023 stating that, when applying for FDA approval, all new medical device developers must submit their plan on how to they will monitor, identify, and address cybersecurity issues. The manufacturer should provide reasonable assurance that their device is protected. Applicants will also need to adjust and implement security updates and patches. They must also provide the FDA with “a software bill of materials,” including any open-source or other software their devices use.
This requirement can allow patients to feel more comfortable as technology advances in the medical field. Luckily, some medical devices are already cyber secure, such as Schiller’s Cardiovit AT-102 G2 & Cardiovit FT-1 EKGs.